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一项随机对照试验的研究方案,旨在测试一款智能手机应用程序对佩戴固定正畸矫治器的青少年口腔健康行为和口腔卫生的影响。

Study protocol of a randomized controlled trial to test the effect of a smartphone application on oral-health behavior and oral hygiene in adolescents with fixed orthodontic appliances.

作者信息

Scheerman Janneke F M, van Meijel Berno, van Empelen Pepijn, Kramer Gem J C, Verrips Gijsbert H W, Pakpour Amir H, Van den Braak Matheus C T, van Loveren Cor

机构信息

Department of Preventive Dentistry, Academic Centre for Dentistry Amsterdam (ACTA), Amsterdam, the Netherlands.

Department of Oral Hygiene, Inholland University, Amsterdam, the Netherlands.

出版信息

BMC Oral Health. 2018 Feb 7;18(1):19. doi: 10.1186/s12903-018-0475-9.

DOI:10.1186/s12903-018-0475-9
PMID:29415697
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5803887/
Abstract

BACKGROUND

Adolescents with fixed orthodontic appliances are at high risk of developing dental caries. To date, new smartphone technologies have seldom been used to support them in the preventive behavior that can help prevent dental caries. After an intervention-mapping process, we developed a smartphone application (the WhiteTeeth app) for preventing dental caries through improved oral-health behavior and oral hygiene. The app, which is intended to be used at home, will help adolescents with fixed orthodontic appliances perform their oral self-care behavior. The app is based on the Health Action Process Approach (HAPA) theory, and incorporates several behavior-change techniques that target the psychosocial factors of oral-health behavior. This article describes the protocol of a randomized controlled trial (RCT) to evaluate the effects of the WhiteTeeth app on oral-health behavior and oral-hygiene outcomes (presence of dental plaque and gingival bleeding) compared with those of care as usual, in patients aged 12-16 with fixed orthodontic appliances.

METHODS/DESIGN: The RCT has two conditions: an experimental group that will receive the WhiteTeeth app in addition to care as usual, and a control group that will only receive care as usual. Care as usual will include routine oral-health education and instruction at orthodontic check-ups. In the western part of the Netherlands 146 participants will be recruited from four orthodontic clinics. Data will be collected during three orthodontic check-ups: baseline (T0), 6 weeks of follow-up (T1) and 12 weeks of follow-up (T2). The primary study outcomes are the presence of dental plaque (measured with a modified Silness and Loë Plaque Index); and gingival bleeding (measured with the Bleeding on Marginal Probing Index). Secondary outcomes include changes in self-reported oral-health behaviors and its psychosocial factors identified by the HAPA theory, such as outcome expectancies, intention, action self-efficacy, coping planning and action control.

DISCUSSION

Since the intervention was designed to target psychosocial factors in the motivational and volitional components of the behavior-change process, we hypothesize that the app will cause greater improvements in oral-health behavior and oral hygiene more than traditional oral-health-promotion programs (i.e., care as usual).

TRIAL REGISTRATION

The trial has been registered with the Dutch Trial Register ( NTR6206 : 20 February 2017).

摘要

背景

佩戴固定正畸矫治器的青少年患龋齿的风险很高。迄今为止,新的智能手机技术很少被用于支持他们采取有助于预防龋齿的预防行为。经过干预映射过程,我们开发了一款智能手机应用程序(WhiteTeeth应用程序),旨在通过改善口腔健康行为和口腔卫生来预防龋齿。该应用程序旨在供在家中使用,将帮助佩戴固定正畸矫治器的青少年进行口腔自我护理行为。该应用程序基于健康行动过程方法(HAPA)理论,并纳入了几种针对口腔健康行为心理社会因素的行为改变技术。本文描述了一项随机对照试验(RCT)的方案,以评估WhiteTeeth应用程序与常规护理相比,对12至16岁佩戴固定正畸矫治器患者的口腔健康行为和口腔卫生结果(牙菌斑和牙龈出血情况)的影响。

方法/设计:该随机对照试验有两种情况:一个实验组,除常规护理外还将接收WhiteTeeth应用程序;一个对照组,仅接受常规护理。常规护理将包括正畸检查时的常规口腔健康教育和指导。在荷兰西部,将从四家正畸诊所招募146名参与者。将在三次正畸检查期间收集数据:基线(T0)、随访6周(T1)和随访12周(T2)。主要研究结果是牙菌斑的存在情况(用改良的Silness和Loë菌斑指数测量);以及牙龈出血情况(用边缘探诊出血指数测量)。次要结果包括自我报告的口腔健康行为及其由HAPA理论确定的心理社会因素的变化,如结果期望、意图、行动自我效能、应对计划和行动控制。

讨论

由于该干预旨在针对行为改变过程中动机和意志成分的心理社会因素,我们假设该应用程序将比传统的口腔健康促进计划(即常规护理)在口腔健康行为和口腔卫生方面带来更大的改善。

试验注册

该试验已在荷兰试验注册中心注册(NTR6206:2017年2月20日)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/25c3/5803887/90bc4cb6a259/12903_2018_475_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/25c3/5803887/06fe447ccdfe/12903_2018_475_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/25c3/5803887/90bc4cb6a259/12903_2018_475_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/25c3/5803887/06fe447ccdfe/12903_2018_475_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/25c3/5803887/90bc4cb6a259/12903_2018_475_Fig2_HTML.jpg

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